I was wondering how others handle checklists and/or criteria for approval for Special Determinations (ie, Children, Pregnant, Cognitively Impaired Adults, etc) at Initial review and for Renewals?
Do you have the criteria for each of the above built into your IRB Reviewer checklist?
And if so, how do you provide the original determination or checklist to the reviewers at the time of renewal since the regulations require the reviewers to confirm that there are no changes to the original determination?
If you don't have the criteria built into your IRB Reviewer checklist, what is your process?
I appreciate any feedback!!!
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Beth Lynch
Senior IRB Analyst
Einstein Healthcare Network
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